Target Health is pleased to announce that it has joined the the Clinical Trials Transformation Initiative (CTTI).

CTTI, a public–private partnership with FDA’s Office of Critical Path Programs and Duke University, is mandated to bring together all interested stakeholders in order to identify practices that, through broad adoption, will increase the quality and efficiency of clinical trials. It is envisioned that this group will seek out new methods and technologies that improve safety, enhance the quality of information from trials, and make the research process more efficient. CTTI will identify best practices, conduct empirical research, and develop new standards for future research efforts. .

For more information about Target Health or any of our software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Our software tools are designed to partner with both CROs and Sponsors

Scientists at The Ohio State University (OSU) have identified a way to predict early outcomes, based on oxygen levels within the tumor, of radiation and 1) ___ for cervical cancer patients. The oxygenation of a 2) ___ is critical for the success of cancer treatment. That’s because the amount of oxygen in a cell is directly correlated with the ability of that cell to repair 3) ___ damage. When the oxygen level is low, a state called 4) ____, the biological changes in tumor cells produced by radiation — that will hopefully destroy the cells — can be repaired, and tumor recurrence is more likely. But when oxygen is present, it reacts with free radical molecules to produce organic peroxide, which causes that damage to be “permanent and irreparable,” says study head Jian Z. Wang, Ph.D., Director of the Radiation Response Modeling Program at the OSU James Cancer Hospital and Solove Research Institute. Inevitably, those well-oxygenated tumor cells die, tumors are less likely to return, and patient 5) ___ rates rise. In their study of 88 women with cervical cancer, the research team measured the level of hemoglobin, the oxygen-carrying 6) ___ in blood, and measured blood supply to the tumor through magnetic resonance imaging (MRI) scans. Blood tests were conducted weekly beginning prior to treatment, and MRI scans were performed before radiation treatment, during radiation at 2-2.5 and 4-5 weeks, and 1-2 months after treatment. Cancer recurrence rates were tracked for up to 9 years. Measurements of tumor 7) ___ just 2 weeks into treatment provided the best predictor of tumor control and disease-free survival. That early glimpse into the future can identify individuals at the greatest risk of having their cancer return, giving doctors the opportunity to adopt more aggressive therapies to improve the prognosis. It is predicted that with further testing, the technique also will prove useful for other types of cancer. The research was described in the talk, “When the Oxygen Level Matters Mostly During Radiation Therapy of Cervical Cancer?” presented July 31, 2008 at the 50th annual meeting of the American Association of Physicists in Medicine.

ANSWERS: 1) chemotherapy; 2) tumor; 3) radiation; 4) hypoxia; 5) survival; 6) molecule; 7) oxygenation